Supplier Qualification and GDP Compliance

by | Oct 3, 2014 | Blog, Bona Fides, EudraGMDP, Good Distribution Practice - GDP, Pharmacy Suppliers, WDA(H)

As a Wholesale Distributor you must now verify that your suppliers are in possession of a valid authorisation AND that they comply with the principals and guidelines of good distribution practices. This will need to be described in your Supplier Qualification SOP and your findings recorded.

EudraGMP public lay out link:  http://eudragmp.ema.europa.eu/

Although the site is still being populated (which will take a full inspection cycle of 4 – 5 years), for verification of suppliers in Europe, the EudraGMP site is available to be used to gather information.

When accessing the site, you will see that there are tabs for various authorisations along with one specifically for GDP compliance. The authorisation tab (i.e.: WDA) is used to check if an authorisation has been issued and its status (i.e.:active/suspended/revoked). The GDP tab will show you GDP Compliance Certificate. This certificate, and the information contained in it, is to be used as part of your risk based assessment of the supplier to provide you with products.

Helpful tip: When searching via a company name, use wildcards (*) to help you obtain the results you are looking for.

For example if searching for Blog It Ltd. Do not simply type Blog in the Authorisation Holder field as nothing will be found, however, if you enter Blog* the search will find all companies with Blog in their name.

Don’t forget to periodically re-visit the site for any updates or changes to your supplier status.

If you are still unsure or need any assistance updating your processes and procedures to meet the requirements of the updated Guidelines on Good Distribution Practices (5 Nov 2013), contact PCL on 01252 302342.

 

 

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